The goal of the Clinical Trials Management Core (CTMC) is to provide protocol administration and data management services to the investigators of the CCSG. Specific responsibilities include planning and designing cancer-related studies with respect to protocol and data management issues, screening patients for eligibility and registering them on study, managing studies in progress, collecting study data, monitoring regulatory compliance, assisting with IRB submissions, ensuring timely reporting of adverse reactions, assisting with preparation of data and review of reports for study analyses, and participating in training, continuing education, and quality assurance procedures. All of these are carried out in compliance with the Good Clinical Practices (GCP) established in 1997 by the FDA. During 2000, 246 protocols were actively managed by the staff of the CTMC. From 1996 through 2001 the CTMC staff were involved in the preparation of more than 150 publications and presentations for the CCSG. A total of 701 subjects were enrolled on these cancer clinical studies during 2000, and 1,943 patients were on follow-up. The CTMC staff collaborates with clinical departments at COH, including Hematology/Bone Marrow Transplantation, Medical Oncology, Surgery, Pediatrics, Neuro-Oncology, Radioimmunotherapy, Radiation Oncology, Clinical Cancer Genetics and our Outreach Program. The CTMC continues to be directed by Joyce Niland, Ph.D., Chair of the Division of Information Sciences and co-directed by David Ikle, Ph.D., Associate Director of Biostatistics. Daily technical supervision of the CTMC Clinical Research Associates (CRAs) is provided by two Clinical Trial Administrators. Quality Control Coordinators assist in training, review data, and conduct Protocol Adherence Evaluations of in-house trials. An Outreach Program is staffed by two Coordinators to collect data at our City of Hope affiliates and to manage our Minority Outreach program. The Operations Specialists assist with policies and procedures, forms design, protocol reporting and maintenance of the Clinical Trials On Line Web site. The Division Systems Administrator supports the central server, workstations, and software installations. Two Data Entry Clerks provide entry of protocol administrative data as well as protocol-specific results.